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Annals of Oncology
P is distinct from that bound by trastuzumab (H) and their complementary
mechanisms of action lead to a more comprehensive HER2 blockade when
combined. Data from the phase III trial CLEOPATRA showed significantly improved
PFS in pts with HER2-positive 1L MBC given P + H + docetaxel (D). As H was not
widely available in the (neo)adjuvant setting prior to CLEOPATRA recruitment, a
relatively low proportion of pts in CLEOPATRA had previously received H. PERUSE
will assess the safety and tolerability of P + H + one of a choice of taxanes (T) as 1L
therapy for pts with HER2-positive metastatic or locally advanced BC. Efficacy
endpoints will also be recorded in PERUSE, in a pt population likely to have
experienced wider exposure to prior H therapy.
Methods: PERUSE is a phase IIIb, multicenter, open-label, single-arm study in pts
with HER2-positive BC who have not been treated with systemic non-hormonal
anticancer therapy for MBC. The planned sample size is 1500. Pts will receive, P:
840mg initial dose, 420mg q3w IV; H: 8mg/kg initial dose, 6mg/kg q3w IV, T: D,
paclitaxel or nab-paclitaxel according to local guidelines. A planned protocol
amendment will allow HR-positive pts to receive endocrine therapy in conjunction
with P + H following completion of T in line with clinical practice. Treatment will be
administered until disease progression or unacceptable toxicity. At baseline, pts must
have an LVEF of ≥50%, ECOG PS of 0, 1 or 2 and must not have received prior
anti-HER2 agents for MBC. Prior H and/or lapatinib in the (neo)adjuvant setting is
allowed, provided there was no disease progression on-treatment. A disease-free
interval of ≥6 months is required. The primary endpoint is safety and tolerability.
Secondary endpoints include PFS, OS, ORR, CBR, duration of response, time to
response and QoL. The final analysis will be carried out when pts have been followed
up for ≥12 months. Interim analyses are planned after enrollment of ∼350, 700 and
1000 pts. Regular interim safety assessments by a DSMB will take place.
Disclosure: D. Miles: I have an interest in relation with one organisation that could
be perceived as a possible conflict of interest in the context of the subject of this
abstract. I have served on Advisory Board Meetings for Roche/Genentech. F. Puglisi:
I have an interest in relation with one organisation that could be perceived as a
possible conflict of interest in the context of the subject of this abstract. I participate
in Advisory Board Meetings for Roche. A. Schneeweiss: I have an interest in relation
with one organisation that could be perceived as a possible conflict of interest in the
context of the subject of this abstract. I serve on Roche Advisory Boards and am in
volved with corporate-sponsored research with Roche. L. Mitchell: I am currently an
employee of F. Hoffmann-La Roche. A. Dünne: I have an interest in relation with
one organisation that could be perceived as a possible conflict of interest in the
context of the subject of this abstract. I am an employee of hoffmann-La Roche.
T. Bachelot: I have an interest in relation with one organisation that could be
perceived as a possible conflict of interest in the context of the subject of this
abstract. I am involved with Roche sponsoredresearch and Roche advisory Board
Meetings. All other authors have declared no conflicts of interest.
Volume 23 | Supplement 9 | September 2012 doi:10.1093/annonc/mds393 | ix143